BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) LOTION [NAVAJO MANUFACTURING COMPANY INC.]

BANANA BOAT (AVOBENZONE, HOMOSALATE, OCTOCRYLENE) LOTION [NAVAJO MANUFACTURING COMPANY INC.]
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NDC 67751-179-01
Set ID 60b42298-c556-534b-e053-2a91aa0a881b
Category HUMAN OTC DRUG LABEL
Packager Navajo Manufacturing Company Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active Ingredients

    Avobenzone 1.8%

    Homosalate 7.0%

    Octocrylene 5.0%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only.

    Do not use on damaged or broken skin.

    When using this product keep out eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

    May stain some fabrics.

  • Directions

    • apply liberally 15 minutes before sun exposure.
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours.

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m.-2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses.
    • children under 6 months: Ask a doctor.
  • Inactive ingredients

    water, cetearyl alcohol, stearyl alcohol, glycerin, phenoxyethanol, acrylates/c12-22 alkyl methacrylate copolymer, caprylyl glycol, cetyl alcohol, carbomer, ceteth-10 phosphate, dicetyl phosphate, coco-glucoside, methylparaben, xanthan gum, propylparaben, sodium hydroxide, disodium edta, hydrogenated methyl abietate, lauryl peg-8 dimethicone, phenylisopropyl dimethicone, polyglyceryl-3 stearate/isostearate/dimer dilinoleate copolymer, sodium ascorbyl phosphate, tocopheryl acetate, aloe barbadensis leaf juice.

  • Other Information

    • protect this product from excessive heat and direct sun
  • Questions or Comments?

    Call 1-800-SafeSun, Mon-Fri

  • Principal Display Panel

    Banana Boat

  • INGREDIENTS AND APPEARANCE
    BANANA BOAT 
    avobenzone, homosalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-179(NDC:63354-890)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-179-011 in 1 PACKAGE12/04/2017
    129 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/04/2017
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-179) , repack(67751-179)

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